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BioWorld - Wednesday, May 31, 2023
Home » Authors » Annette Boyle

Annette Boyle

Articles

ARTICLES

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Pear sliced into four parts at auction for $6M

May 30, 2023
By Annette Boyle
No Comments
A financial freefall left prescription digital therapeutic pioneer Pear Therapeutics Inc. cut into four pieces following a bankruptcy judge’s approval of the sale of its assets for a total of $6.05 million. Sleep-focused Nox Health Group took the biggest bite, acquiring the FDA-cleared Somryst PDT for $3.9 million. Other buyers included Harvest Bio LLC, Click Therapeutics Inc. and Welt Corp. Ltd. The total generated from the assets was woefully short of the company’s $32 million in debt.
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Study shows Exact benefit of early cancer diagnosis

May 26, 2023
By Annette Boyle
No Comments
Exact Sciences Corp.’s long-term analysis of results from the Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing (DETECT-A) study found that all patients diagnosed and treated for stage I or II cancers identified through its blood-based multi-cancer early detection (MCED) test remained cancer-free more than four years after diagnosis. Half of all the participants with cancer detected remained alive at four years, notable because most of the detected cancers had no recommended screening tests or standards. The results will be presented at the American Society of Clinical Oncology meeting June 2-6.
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Medtronic to acquire Eoflow for $738M to boost diabetes business

May 25, 2023
By Annette Boyle
No Comments
Medtronic plc agreed to acquire Eoflow Co. Ltd., the manufacturer of Eopatch, a tubeless, wearable and fully disposable insulin delivery service, for $738 million. The deal, which is expected to provide a significant boost to Medtronic’s beleaguered diabetes unit, is slated to close in the second half of 2023. The deal announcement coincided with Medtronic’s release of its fourth quarter results for fiscal 2023.
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A quick two step: Artivion granted PMA for Perclot, transfers it to Baxter for $18.75M

May 23, 2023
By Annette Boyle
No Comments
Artivion Inc. (formerly Cryolife Inc.) received U.S. FDA premarket application (PMA) approval of its Perclot absorbable hemostatic system and promptly sold the product line to Baxter International Inc., in keeping with the terms of an agreement announced in July 2021. Artivion will begin shipping Perclot product to Baxter following receipt of a milestone payment of $18.75 million in cash, of which $4.5 million will go to Artivion’s former partner Starch Medical Inc.
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FDA clears Beta Bionics’ Ilet bionic pancreas

May 22, 2023
By Annette Boyle
No Comments
Beta Bionics Inc. received U.S. FDA clearance for its Ilet Bionic Pancreas, an automated insulin-delivery (AID) system that calculates 100% of insulin doses without requiring carb counting or manual boluses. The system—a pump plus dosing decision software—is indicated for people aged six years and up with type 1 diabetes.
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Investors eye early identification of disease through retinal imaging with $12M collaboration

May 18, 2023
By Annette Boyle
No Comments
A collaboration between Aegis Ventures LLC and Northwell Holdings invested $12 million to launch New York-based Optain Inc., an artificial intelligence company created to enable early identification and disease prevention through retinal imaging. Retinal imaging is well known for identifying eye diseases including diabetic retinopathy, age-related macular degermation and glaucoma, but it can also provide insight into cardiovascular and neurological conditions.
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Shockwave launches first all-female study of PCI

May 17, 2023
By Annette Boyle
No Comments
Shockwave Medical Inc. enrolled the first patient in its EMPOWER CAD study, the first prospective, all-female study of percutaneous coronary intervention (PCI). The study seeks to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions. Women have historically been underrepresented in cardiovascular trials and have had less favorable outcomes in response to therapies.
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FDA approves Abbott's spinal cord stimulator for non-surgical back pain

May 16, 2023
By Annette Boyle
No Comments
Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.
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Ravgen snags another $100M from Labcorp in prenatal diagnostic patent dispute

May 15, 2023
By Annette Boyle
No Comments
Ravgen Inc.’s patent litigation strategy could add another $100 million to the company’s coffers, assuming enhanced damages in its suit against Laboratory Corp. of American Holdings (Labcorp) awarded on May 12 are sustained on appeal. The additional damages are on top of the $272.5 million awarded in September for “egregious” violations of Ravgen’s patents on non-invasive prenatal testing methods.
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Philips to pay $62M for violation of FCPA in China

May 15, 2023
By Annette Boyle
No Comments
The U.S. Securities and Exchange Commission (SEC) reported that Royal Philips NV will pay more than $62 million in connection with “irregularities in the medical device industry” related to its Chinese subsidiaries. The charges arise from actions that occurred between 2014 and 2019 from sales of medical diagnostic equipment in China.
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